Manufacturing Engineer II

• Apr 2022 - Present

Manufacturing Engineer I

• Mar 2021 - Apr 2022

Develop Master Validation Plan, to support design, validate manufacturing process for Molecular diagnostic products and point of care product. Design and Implement manufacturing processes including Product/process flow, production equipment for new product development ensuring best manufacturing practices are followed. Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities Create the 21 CFR Part 11… Show more Develop Master Validation Plan, to support design, validate manufacturing process for Molecular diagnostic products and point of care product. Design and Implement manufacturing processes including Product/process flow, production equipment for new product development ensuring best manufacturing practices are followed. Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities Create the 21 CFR Part 11 Assessments, cGMP and Criticality Assessments, User Requirement Specifications, and other documents to support the validation efforts. Identify deviations from established product or process standards and provide recommendations for resolving deviations. Assist in training equipment operators or other staff on validation protocols and standard operating procedures. Created and revised Process Failure Mode Effects Analysis (PFMEA) and Design Failure Mode Effects Analysis (DFMEA). Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols. Generating manufacturing documentation and processes (BOM Management, assembly and test methods, tools, procedures & drawings. Involved in validation process coordination within cross-functional departments such as Technical Operations, Engineering, and Quality Assurance, and regulatory affairs. Support quality and compliance by adhering to all procedures, work instructions, and forms per the Quality Management Systems (QMS).

Manufacturing Quality Engineer

• Jul 2020 - Dec 2020

Develop and Execute validation protocols (Engineering evaluation, IQ/OQ/PQ) of product, process, and their test equipment. Designing and specifying inspection and testing procedures/systems to ensure products conform to specifications and quality standards. Performed Design of Experiments (DoE) on manufacturing equipment/process using Minitab 17 and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R. Responsible for tooling and… Show more Develop and Execute validation protocols (Engineering evaluation, IQ/OQ/PQ) of product, process, and their test equipment. Designing and specifying inspection and testing procedures/systems to ensure products conform to specifications and quality standards. Performed Design of Experiments (DoE) on manufacturing equipment/process using Minitab 17 and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R. Responsible for tooling and process design, documentation and utilizing Process Failure Mode and Effect Analysis (pFMEA) to identify necessary process controls and risk analysis. Performing statistical analysis to determine manufacturing process reproducibility and capability test method (Gage R&R, Cpk/Ppk, etc.) using MINITAB. Ability to use inspection test equipment such as Sprint/Vision system, calipers, micrometers, and Comparators, CMM/VMM, etc. Performed Root Cause Analysis on non-compliant product after execution the validation and implementing engineering solutions to resolve issues. Cross trained to create quality plans, SOP’s, troubleshoot equipment’s and support Sustaining Engineering team. Show less Develop and Execute validation protocols (Engineering evaluation, IQ/OQ/PQ) of product, process, and their test equipment. Designing and specifying inspection and testing procedures/systems to ensure products conform to specifications and quality standards. Performed Design of Experiments (DoE) on manufacturing equipment/process using Minitab 17 and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R. Responsible for tooling and… Show more Develop and Execute validation protocols (Engineering evaluation, IQ/OQ/PQ) of product, process, and their test equipment. Designing and specifying inspection and testing procedures/systems to ensure products conform to specifications and quality standards. Performed Design of Experiments (DoE) on manufacturing equipment/process using Minitab 17 and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R. Responsible for tooling and process design, documentation and utilizing Process Failure Mode and Effect Analysis (pFMEA) to identify necessary process controls and risk analysis. Performing statistical analysis to determine manufacturing process reproducibility and capability test method (Gage R&R, Cpk/Ppk, etc.) using MINITAB. Ability to use inspection test equipment such as Sprint/Vision system, calipers, micrometers, and Comparators, CMM/VMM, etc. Performed Root Cause Analysis on non-compliant product after execution the validation and implementing engineering solutions to resolve issues. Cross trained to create quality plans, SOP’s, troubleshoot equipment’s and support Sustaining Engineering team. Show less

Quality Engineer

• Feb 2020 - Jul 2020

Initiate and maintain Validation Protocols to regulatory and customer requirements. ● Investigate incidents and problems to determine cause; institute corrective and preventive actions planning while closing deviations. ● Investigate and determine root cause of product quality issues and defects and implements solutions to resolve issues; assist production and other personnel with the Corrective Action process ● Develop inspection fixtures and implement suggestions with regards to… Show more Initiate and maintain Validation Protocols to regulatory and customer requirements. ● Investigate incidents and problems to determine cause; institute corrective and preventive actions planning while closing deviations. ● Investigate and determine root cause of product quality issues and defects and implements solutions to resolve issues; assist production and other personnel with the Corrective Action process ● Develop inspection fixtures and implement suggestions with regards to procedures, standards and ● Work closely with the metrology team to schedule and drive product first article inspections, capability studies, gage R&Rs, etc. Takes care to review data to ensure accuracy prior to submitting to customers ● Identify and implement continual improvement opportunities to streamline production and quality systems and processes. ● Serve as the quality representative on cross-functional new product development and production teams. Show less Initiate and maintain Validation Protocols to regulatory and customer requirements. ● Investigate incidents and problems to determine cause; institute corrective and preventive actions planning while closing deviations. ● Investigate and determine root cause of product quality issues and defects and implements solutions to resolve issues; assist production and other personnel with the Corrective Action process ● Develop inspection fixtures and implement suggestions with regards to… Show more Initiate and maintain Validation Protocols to regulatory and customer requirements. ● Investigate incidents and problems to determine cause; institute corrective and preventive actions planning while closing deviations. ● Investigate and determine root cause of product quality issues and defects and implements solutions to resolve issues; assist production and other personnel with the Corrective Action process ● Develop inspection fixtures and implement suggestions with regards to procedures, standards and ● Work closely with the metrology team to schedule and drive product first article inspections, capability studies, gage R&Rs, etc. Takes care to review data to ensure accuracy prior to submitting to customers ● Identify and implement continual improvement opportunities to streamline production and quality systems and processes. ● Serve as the quality representative on cross-functional new product development and production teams. Show less

Quality Engineer

• Oct 2019 - Feb 2020

Plan and execute validation protocols including IQ, OQ, PQ and Revalidation as required in regard to TMV and Process validation towards the injection molding application process ● Planning and implementing quality testing procedures, scheduling project/quality plans (QP), and preparing documents involved Writing the Change control Notices (CCN), NCMR, CAPA, etc. ● Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance ● Responsible in… Show more Plan and execute validation protocols including IQ, OQ, PQ and Revalidation as required in regard to TMV and Process validation towards the injection molding application process ● Planning and implementing quality testing procedures, scheduling project/quality plans (QP), and preparing documents involved Writing the Change control Notices (CCN), NCMR, CAPA, etc. ● Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance ● Responsible in program / project change control activities including the creation, maintenance and compliance of test protocols, test plans, test cases, summary reports, test / process deviations, standard operating procedures, work instructions, purchasing specifications, incoming inspection records, inspection/ quality plans, etc. Show less Plan and execute validation protocols including IQ, OQ, PQ and Revalidation as required in regard to TMV and Process validation towards the injection molding application process ● Planning and implementing quality testing procedures, scheduling project/quality plans (QP), and preparing documents involved Writing the Change control Notices (CCN), NCMR, CAPA, etc. ● Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance ● Responsible in… Show more Plan and execute validation protocols including IQ, OQ, PQ and Revalidation as required in regard to TMV and Process validation towards the injection molding application process ● Planning and implementing quality testing procedures, scheduling project/quality plans (QP), and preparing documents involved Writing the Change control Notices (CCN), NCMR, CAPA, etc. ● Developing testing methods, writing quality testing procedures, and checking quality to ensure compliance ● Responsible in program / project change control activities including the creation, maintenance and compliance of test protocols, test plans, test cases, summary reports, test / process deviations, standard operating procedures, work instructions, purchasing specifications, incoming inspection records, inspection/ quality plans, etc. Show less

Quality Engineer

• Jul 2019 - Oct 2019

Plan and execute validation protocols including IQ, OQ, PQ and Validation as required in regard to TMV and Process validation ● Developed OQ Protocol / Summary Report, PQ Protocol / Summary Report and Validation Summary Report summarizing the validation activities and Deviations resulted from OQ/PQ Execution ● Experience with test protocol documentation, Design Reviews, and the complete DMR/Master Batch Record documentation ● Supported the Design History Files(DHF) and updated them… Show more Plan and execute validation protocols including IQ, OQ, PQ and Validation as required in regard to TMV and Process validation ● Developed OQ Protocol / Summary Report, PQ Protocol / Summary Report and Validation Summary Report summarizing the validation activities and Deviations resulted from OQ/PQ Execution ● Experience with test protocol documentation, Design Reviews, and the complete DMR/Master Batch Record documentation ● Supported the Design History Files(DHF) and updated them as per the changes made in the due course of design and development of Devices and Equipment ● Ensured compliance to 21 CFR Part 820 and Customer Specifications. ● Equipment Qualification Validation: preparation and execution of the Protocols for the Packaging equipment of advanced wound care, medical device fixation etc. ● Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters. ● Acceptance criteria of new raw materials, in process quality inspections (AQL level sampling plan), final product release criteria and preventive maintenance Show less Plan and execute validation protocols including IQ, OQ, PQ and Validation as required in regard to TMV and Process validation ● Developed OQ Protocol / Summary Report, PQ Protocol / Summary Report and Validation Summary Report summarizing the validation activities and Deviations resulted from OQ/PQ Execution ● Experience with test protocol documentation, Design Reviews, and the complete DMR/Master Batch Record documentation ● Supported the Design History Files(DHF) and updated them… Show more Plan and execute validation protocols including IQ, OQ, PQ and Validation as required in regard to TMV and Process validation ● Developed OQ Protocol / Summary Report, PQ Protocol / Summary Report and Validation Summary Report summarizing the validation activities and Deviations resulted from OQ/PQ Execution ● Experience with test protocol documentation, Design Reviews, and the complete DMR/Master Batch Record documentation ● Supported the Design History Files(DHF) and updated them as per the changes made in the due course of design and development of Devices and Equipment ● Ensured compliance to 21 CFR Part 820 and Customer Specifications. ● Equipment Qualification Validation: preparation and execution of the Protocols for the Packaging equipment of advanced wound care, medical device fixation etc. ● Responsible for assisting in creating all applicable process documentation to guarantee production processing consistent within validated parameters. ● Acceptance criteria of new raw materials, in process quality inspections (AQL level sampling plan), final product release criteria and preventive maintenance Show less

Manufacturing Associate

• Dec 2018 - Jun 2019

Resolves quality issues by identifying problems, examining solution options, implementing action plans, and providing resources. ● Focus on daily assignment in group environments to include safety and quality in department and other requiring assistance and maintains a safe, organized, and clean working environment by complying with procedures, rules, and regulations. ● Reviews component measurement data to evaluate compliance. ● Provides detailed documentation review and… Show more Resolves quality issues by identifying problems, examining solution options, implementing action plans, and providing resources. ● Focus on daily assignment in group environments to include safety and quality in department and other requiring assistance and maintains a safe, organized, and clean working environment by complying with procedures, rules, and regulations. ● Reviews component measurement data to evaluate compliance. ● Provides detailed documentation review and provide timely and clear feedback to supplier to guide them toward the efficient closure of gaps identified. ● Created Work Instructions for the operation of Product Assembly. ● Process knowledge (e.g., injection molding, stamping, welding and Assembly) is desired to effectively drive changes required to achieve compliance to PPAP requirements. ● Acceptance criteria of new raw materials, in-process quality inspections, final product release criteria and preventive maintenance. ● Assist in the development of manufacturing builds and processes by using industry techniques and practices. ● Executing to project plans and schedules for work activities. ● Maintain the Process and assembly line steady using MRP System. Show less Resolves quality issues by identifying problems, examining solution options, implementing action plans, and providing resources. ● Focus on daily assignment in group environments to include safety and quality in department and other requiring assistance and maintains a safe, organized, and clean working environment by complying with procedures, rules, and regulations. ● Reviews component measurement data to evaluate compliance. ● Provides detailed documentation review and… Show more Resolves quality issues by identifying problems, examining solution options, implementing action plans, and providing resources. ● Focus on daily assignment in group environments to include safety and quality in department and other requiring assistance and maintains a safe, organized, and clean working environment by complying with procedures, rules, and regulations. ● Reviews component measurement data to evaluate compliance. ● Provides detailed documentation review and provide timely and clear feedback to supplier to guide them toward the efficient closure of gaps identified. ● Created Work Instructions for the operation of Product Assembly. ● Process knowledge (e.g., injection molding, stamping, welding and Assembly) is desired to effectively drive changes required to achieve compliance to PPAP requirements. ● Acceptance criteria of new raw materials, in-process quality inspections, final product release criteria and preventive maintenance. ● Assist in the development of manufacturing builds and processes by using industry techniques and practices. ● Executing to project plans and schedules for work activities. ● Maintain the Process and assembly line steady using MRP System. Show less